J&J to resume ops at Mulund plant after HC reprieve

In major relief coming for Johnson and Johnson, the Bombay HC has set aside the impugned Maharasthra FDA order that had cancelled its license to manufacture cosmetics as its facility in Mulund. (Read More)

The Bombay HC has remanded the matter back to the Appellate Authority, directing it to hear J&J’s application afresh. Armed with this order from the Bombay HC, J&J can now resume operations at its Mulund facility, which had been shut since June. J&J encountered trouble with the Maharasthra FDA after it issued, in March, an order canceling the company’s license to manufacture cosmetics from the Mulund plant. The FDA had contended that it believed that 15 batches of baby powder, manufactured in 2007, contained Ethylene Oxide. Ethylene oxide is known to be a chemical that causes cancer. Maharasthra FDA had also contended that Ethylene Oxide had been used in a sterilization process that was not registered with the FDA. The FDA also contended that no tests had been conducted top ensure that no residues of Ethylene Oxide were found in the products. In June, J&J appealed against the order before the Minister of State (MoS) for FDA, Manohar Naik. However, the appeal was dismissed and the FDA’s order, canceling the license, was upheld leading to the closure of the Mulund plant. J&J had then sought relief by appealing against the order in the Bombay HC. J&J maintained that ethylene oxide had only been used for that specific batch of baby powder back in 2007. J&J also contended that the Drug and Cosmetics Act did not require the company to register the process with the FDA. J&J also argued that the same act also did not require the tests, specified by FDA, to be conducted. The company claimed that no complaints against the use of the specified products have been made. J&J also made an application for the repeating the process of sterilization process with the use of ethylene oxide, allowing the FDA to test for any harmful residues. Meanwhile, Ajit Telang, a former employee, who claims to have blown the whistle on the company’s use of ethylene oxide sought to intervene in the matter, citing public interest. Telang argued that the substance takes years to manifest in the form of the cancerous conditions. The Bombay HC passed the order today, without prejudice to Telang’s rights to make a similar application for intervention before the appellate authority.